Pilot Study: Relaxation and Guided Imagery in Hispanic Persons Diagnosed With Fibromyalgia

Pain Clinical Trial

Official title:

Effects of Guided Imagery on Pain, Distress, Functional Status and Self-Efficacy in Hispanics Diagnosed With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00512590
• Other study ID #: Menzies-1
• Status: Completed
• Phase: N/A
• First received: August 3, 2007
• Last updated: August 3, 2007
• Start date: April 2005
• Est. completion date: June 2006

Study information

• Verified date: August 2007
• Source: Florida International University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this pilot study was to test the effects of a 10-week relaxation and guided imagery intervention on pain perception, functional status, self-efficacy and levels of distress in Hispanic adults diagnosed with fibromyalgia.

Description:

Fibromyalgia (FM), a chronic widespread pain condition with an unknown pathogenesis and no known cure, affects 2 to 4 million persons in the adult US population. One of the most common conditions seen in rheumatology clinics world wide, including the US, Mexico, and Spain, FM is accompanied by various co-occurring symptoms such as fatigue, disturbed sleep, stiffness and depression. While studies of fibromyalgia in Hispanics have been reported in Spain, Brazil and Argentina, very few such studies have been reported in the United States. This gap exists despite data indicating that there are a reported 16 million Hispanics with rheumatic diseases in the US and that Hispanics (self-identified) form the fastest growing minority group in this country.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ages 18 and older

• diagnosis of fibromyalgia based on the American College of Rheumatology criteria and documented by the patient's primary physician

• a minimum of a 6th grade education level

• an ability to understand and sign the consent form and understand and complete the intervention (pencil and paper) assignments.

Exclusion Criteria:

• presence of other systemic rheumatologic conditions such as rheumatoid arthritis, lupus, and/or Sjogren's Disease

• adequate functional status as indicated by a Fibromyalgia Impact Questionnaire score < 20

• inadequate cognitive status as evidenced by a Mini-Mental State Exam score < 25

• history of epilepsy

• major communicative disorder.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Distress
• Fibromyalgia
• Functional Status
• Myofascial Pain Syndromes
• Pain
• Self-Efficacy

Intervention

Behavioral:
• Relaxation and Guided Imagery
The intervention consisted of 3 relaxation and guided imagery audiotapes used in a proscribed order for 6 weeks and used in any order for weeks 7 through 10. Protocol: Tape 1: Basic Relaxation used for weeks 1 and 2. Tape 2: Pleasant Scene Imagery to elicit sensory involvement for enhanced sense of overall well-being; used for weeks 3 and 4. Tape 3: End-State Imagery designed to facilitate improved symptom management; used for weeks 5 and 6. Any of the tapes used as often as desired but at least once daily for weeks 7 to 10.

Locations

Country	Name	City	State
United States	Florida International University	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida International University	Sigma Theta Tau International (Nursing Honor Society)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain as measured by Short-Form McGill Pain Questionnaire		10 weeks
Secondary	Functional Status as measured by the Fibromyalgia Impact Questionnaire		10 weeks
Secondary	Self-Efficacy as measured by the Arthritis Self-Efficacy Scale adapted for FM		10 weeks
Secondary	Distress as measured by the 17-item Mental Health Inventory		10 weeks